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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY MITEK 4580 FMS DUO+ PUMP/SHAVER COMBO; FMS EQUIPMENT SYSTEMS
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DEPUY MITEK 4580 FMS DUO+ PUMP/SHAVER COMBO; FMS EQUIPMENT SYSTEMS Back to Search Results
Catalog Number 284580
Device Problem Unknown (for use when the device problem is not known) (2204)
Patient Problem Extravasation (1842)
Event Date 02/19/2015
Event Type  Injury  
Event Description
No aspiration / circulation.Non functional tubulures.No aspiration.Tubulures and cutters have been replaced several times and another aspiration has been used in order to drain the liquid infused to the patient and to complete the procedure.The procedure has been extended of more than 1 hour.No consequences to the patient.
 
Manufacturer Narrative
Attempts have been made to retrieve additional information about the event and device.The additional information will reportedly be forwarded to depuy mitek however it is not known if it will be received within the 30 day reporting requirement, therefore depuy mitek would like to file this initial medwatch report at this time.When and if additional information is received it will be reflected in a follow-up medwatch report.
 
Manufacturer Narrative
The complaint device was received by our service center.The device was evaluated visually and functionally.No anomalies were found that would have contributed in the reported failure.Servicing involved only cosmetic issues that would not affect the proper functioning of the device.The test report communicated that the measured flow is in defined tolerances and the suction performance is fully functional in accordance with expectations.The reported failure could not be confirmed and a root cause could not be determined.Further a review into the depuy mitek complaints system revealed two other dissimilar complaints for this device.At this point in time, no corrective action is required and no further action is warranted.However, depuy mitek will continue to track any related complaints within this device family as a means of monitoring the extent with which this complaint is observed in the field.
 
Event Description
No aspiration / circulation.Non functional tubulures.No aspiration.Tubulures and cutters have been replaced several times and another aspiration has been used in order to drain the liquid infused to the patient and to complete the procedure.The procedure has been extended of more than 1 hour.No consequences to the patient.
 
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Brand Name
4580 FMS DUO+ PUMP/SHAVER COMBO
Type of Device
FMS EQUIPMENT SYSTEMS
Manufacturer (Section D)
DEPUY MITEK
325 paramount drive
quality department
raynham MA 02767
Manufacturer (Section G)
DEPUY MITEK
325 paramount drive
na
raynham MA 02767
Manufacturer Contact
eric so
325 paramount drive
quality department
raynham, MA 02767
8003824682
MDR Report Key4703357
MDR Text Key19642975
Report Number1221934-2015-00703
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K954465
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility,Company Representative,Distributor
Reporter Occupation Health Professional
Remedial Action Other
Type of Report Initial,Followup
Report Date 03/20/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/17/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number284580
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/12/2015
Is the Reporter a Health Professional? Yes
Distributor Facility Aware Date03/20/2015
Event Location Hospital
Date Report to Manufacturer03/20/2015
Date Manufacturer Received03/20/2015
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Outcome(s) Other; Required Intervention;
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